Supporting Information - Cross-programme calls
FOR APPLICANTS APPLYING TO THE CALLS:
Solid Organ Replacement
Perinatal Mental Health
About this supporting information
This document contains information to assist applicants submitting either a Stage 1 or Stage 2 application form for the call for ambitious data-enabled trials, health services and public health care research studies.
Applications for funding are made online through the NIHR Evaluation, Trials and Studies Coordinating Centre Management Information System (NETSCC MIS). You must register or log-in to the NETSCC MIS to complete and submit your application.
Please also ensure that you have read the Stage 1 guidance notes fully before contacting us with any queries. We have endeavoured to cover all necessary information relating to the application form through these resources. Incorrectly completed applications may be rejected.
The Programmes participating in this call are:
- Efficacy and Mechanism Evaluation (EME)
- Health Services and Delivery Research (HS&DR)
- Health Technology Assessment (HTA)
- Public Health Research (PHR)
Chief investigators must be based in England, Scotland, Wales or Northern Ireland. Applicants who require further guidance may wish to submit the pre-submission form, including the population, intervention, comparator, outcome and setting as appropriate.
We welcome applications that are within the participating programmes' remits from all sectors. Applicants are strongly advised to consider establishing partnerships with other relevant sectors or organisations to demonstrate they have the full breadth of expertise to carry out their proposed research in their applications. We recommend that lead applicants from Industry contact the CrossProgramme office (email@example.com ) prior to submitting an application. If you are planning co-funding with a charity partner, please discuss your plans with the CrossProgramme office.
Applicants are asked to:
- Follow Good Clinical Practice guidelines when planning how studies, particularly RCTs, will be supervised. Further advice specific to each topic will be given by the Programme at proposal Stage 2 and contracting stages.
- Note that trials involving medicinal products must comply with "The Medicines for Human Use (Clinical Trials) Regulations 2004". In the case of such trials, the Department of Health and Social Care (DHSC) expects the employing institution of the chief investigator to be nominated as the sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. The DHSC is prepared to accept the nomination of multiple sponsors. Applicants who are asked to submit a Stage 2 proposal will need to obtain confirmation of a sponsor(s) to complete their application. The DHSC reserve the right to withdraw from funding the project if they are not satisfied with the arrangements put in place to conduct the trial.
Proposal resubmission policy
Please note that an unsuccessful proposal cannot normally be resubmitted to this or any other programme within one year of the original decision letter, unless applicants can demonstrate that it has changed significantly and is essentially a new proposal or the applicant has been invited to resubmit.
We have an obligation to keep data secure and to use it appropriately. To fulfil our obligations under law and as a result of our contract with the Department of Health and Social Care, we adopt various procedures to use and protect data. This will impact on how we deal with you and your joint applicants.
The Department of Health and Social Care, National Institute for Health Research (DHSC NIHR) is the Data Controller under the Data Protection Act 1998 ('the Act'). Under the Data Protection Act, we have a legal duty to protect any information we collect from you. You should be aware that information given to us might be shared with other DHSC NIHR bodies for the purposes of statistical analysis and other DHSC NIHR research management purposes. We also reserve the right to share, in confidence, details of your application with other approved research funding organisations outside NIHR in order to coordinate research activity in the UK.
Information collected from you will not be passed to any third party outside the NIHR except specifically as detailed above without your consent except where we are under a statutory obligation or entitled to do so by law. Applicants may be assured that DHSC NIHR is committed to protecting privacy and to processing all personal information in a manner that meets the requirements of the Act.
Data Security - data about you
Personal information will be held on a database in the NETSCC password-protected network that is available only to NETSCC staff. Your details and those of your co-applicants will be retained by NETSCC on behalf of the NIHR and Department of Health and Social Care to facilitate the running of the Programme. If your application is successful at any stage of our process, your name, and the details of the sponsoring organisation, will appear on the NIHR website. In addition, once funding has been agreed and the contract signed, your details will appear in other literature as a grant holder and will be passed to the Department of Health and Social Care for inclusion in their publicly available databases of research projects.
Your name and those of your co-applicants will be added to the NETSCC MIS mailing list. This means that you will be sent updates on all the NETSCC programmes. If you have any questions, or if you would prefer not to receive routine and/or general communications, please contact us at: firstname.lastname@example.org.
Research Design Service
Applicants are recommended to seek advice from suitable methodological support services, at an appropriate stage in the development of their research idea and application. It is advisable to make contact at an early a stage as possible to allow sufficient time for discussion and a considered response.
The NIHR Research Design Service can advise on appropriate NIHR programme choice, and developing and designing high quality research grant applications.
Clinical Trials Unit Support
Clinical Trials Units are regarded as an important component of many trial applications, and can advise and participate throughout the process from initial idea development through to project delivery and reporting. However, they may not be essential for all types of studies. If you feel this is the case, please justify the reasons on your application.
If you are looking for a CTU to collaborate with in your application, then the following sources can provide more help:
NIHR CTU Support Funding provides information on units receiving funding from the NIHR to collaborate on research applications to NIHR programmes and funded projects.
The UKCRC CTU Network provides a searchable information resource on all registered units in the UK, and lists key interest areas and contact information.
The NIHR Clinical Research Network
The NIHR Clinical Research Network (CRN) supports health and social care research taking place in NHS and non-NHS settings. This also now includes public health research. The CRN provides expert advice and support to plan, set up and deliver research efficiently.
Clinical Trials Toolkit
Researchers designing or undertaking clinical trials are encouraged to consult the Clinical Trials Toolkit. This NIHR resource is a website designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements. Although primarily aimed at those involved in publicly funded Clinical Trials of Investigational Medicinal Products (CTIMPs), the Toolkit will also benefit researchers and R&D staff working on trials in other areas, who will find useful information and guidance of relevance to the wider trials environment.
The NIHR expects the active involvement of patients and the public in the research it supports, including research undertaken as part of an individual training award. NIHR recognise that the nature and extent of active patient and public involvement is likely to vary depending on the context of each study or award. The term involvement refers to an active partnership between patients, members of the public and researchers in the research process. This can include, for example, involvement in the choice of research topics, assisting in the design, advising on the research project or in carrying out the research.
It is important that you describe in as much detail as possible how patients and the public have been involved in the development of the application as well as plans for involvement in the proposed research. Please note that this does not refer to the recruitment of patients or members of the public as participants in the research.
Further information and resources can be found on the INVOLVE website. This includes a detailed definition of patient and public involvement in research, briefing notes for researchers on how to involve patients and the public and an involvement cost calculator and budgeting guide. The NIHR Research Design Service provide advice on developing research applications including involving patients and the public and the James Lind Alliance has a step-by-step guide on involvement in research identification and priority setting.
Advice on Non-standard methodologies
The Methodology Advisory Service for Trials (MAST), offered by the Network of Hubs for Trials Methodology Research is a resource for resolving non-standard methodological issues. Referrals to MAST, should ideally be made through Clinical Trials Units (CTUs).
Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study is led from England and involves the NHS in England you should apply for HRA approval.
If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006. Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA who make decisions with advice from the Confidentiality Advisory Group. (CAG)
To take advantage of the growing utility of routine data (such as HES, GP records etc.), we would encourage investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.
Information on the responsibilities of key research stakeholders including Sponsors, Chief Investigators and Research Teams are summarised in the UK policy framework for health and social care research.
Reasonable costs and value for money
The Programmes accept that some variance in costs is likely to occur between the Stage 1 and Stage 2 applications. The Programmes will carefully scrutinise all Stage 2 application costs and any variance from the first stage. All costs need to be fully justified by the applicants to reassure that the study offers good value for money for the NHS.
There are no fixed limits on the duration of projects or funding, and proposals should be tailored to fully address the research problem. Research costs are the costs of the research activity itself. These include data collection, analysis, other activities needed to answer the research questions, trial registration (if required) and the salary and indirect costs of staff employed to carry out the research.
It is important that consideration is given to all costs in relation to NHS support and treatment costs, where appropriate, and the accurate values for these are included. It should be noted that applicants are expected to have contacted the appropriate Trust/s regarding the NHS support and treatment costs that may be required if their research is funded. If the costs are felt to be material, a letter of support may be provided from the Trust/s concerned as part of the Stage 2 proposal.
If you are unsure of how to attribute the costs between research and NHS support and treatment costs, please refer to the following guidance on ‘Attributing the costs of health & social care Research & Development (AcoRD)’
Higher Education Institutions (HEIs)
HEIs should determine the Full Economic Cost (FEC) of their research using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used.
NHS body or provider of NHS services in England
For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.
Other Partner Organisations
- If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.
- If you are an ‘other partner’ organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.
The total costs on the Stage 1 form should include the figures at the appropriate rate, so the total should reflect HEI figures at 80% and non-HEI figures at 100%. When completing the Stage 2 form, the figure submitted should be 100%, any reductions to FEC are automatically calculated by the system prior to submission.
UK Biobank is a major national health resource with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses. As such, applicants are encouraged to consider whether Biobank may be able to provide suitable data for their study, rather than request funding for unnecessary new data collection. We do not want to discourage establishment of new cohorts of participants and their data where this is necessary to address the research questions under consideration, our aim is to avoid applications for funding to set up Biobank-like cohorts where the use of Biobank would prevent wasteful duplication of Biobank-like activities.
UK Biobank has recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis as well as detailed information about themselves. The health of members of this large cohort will be followed over the coming years and the participants have consented to be approached about health research. www.ukbiobank.ac.uk/
Applicants are encouraged to consider whether Biobank may be able to provide suitable data for their study. We do not want to discourage establishment of new collections of participants and their data where this is necessary to address the research questions under consideration, our aim is to avoid applications for funding to set up Biobank-like cohorts where the use of Biobank would prevent wasteful duplication of Biobank-like activities.
Requirements for systematic reviews to be registered with PROSPERO
Applicants undertaking systematic reviews should note the commitment of NIHR to register them in the PROSPERO database. PROSPERO was developed by the NIHR’s Centre for Reviews and Dissemination (CRD), and is the first online facility to register systematic reviews for research about health and social care from all around the world. Access is completely free and open to the public. PROSPERO registration is a condition of NIHR funding for eligible systematic reviews. Link to PROSPERO website: http://www.crd.york.ac.uk/prospero/.
NIHR Carbon Reduction Guidelines
Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the NIHR Carbon Reduction Guidelines.
In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at:
Guidance for using the electronic online Stage 1 application form
To Access the Application form for Stage 1 applications only
Select the call to which you wish to apply for on the funding opportunity page on the NIHR website. From within the call details page press the ‘Click here to apply’ button to access the Stage 1 application form. This also provides call specific supplementary information e.g. the commissioning brief or specification document. This will direct you to the NETSCC MIS login page. If you already have a username (email address) and password, enter these details or, if you have not yet registered, complete the short registration process. You will then be directed to the confirmation page for the specific call. If this is the correct call, click on the Apply button and this will start the application process. Clicking Cancel will return you to your ‘home page’.
Applying for a funding opportunity creates a task called ‘Stage 1 Application’. This task will be available for you to complete until 1pm on the closing date as indicated on the research call and on your task list.
The ‘Stage 1 Application’ task can be accessed at any time until you either submit the application (using the Submit button in the application process which will appear once all the validation is complete) or the call closes.
Clicking on the Stage 1 Application link takes you to the application’s main page where you can complete your application information (clicking on this link will not submit an incomplete application).
Additional guidance will be available on most screens as you progress through your application.
The NETSCC MIS can always be accessed directly at https://netscc-mis.nihr.ac.uk/ for you to go to your home page where all your applications and other tasks will be listed.
To submit a Stage 1 application
In order to submit a Stage 1 application to the programme you must:
- Complete all mandatory fields as indicated with a red asterisk *. The final review and submit page of the application provides a final check of the mandatory fields as well as providing reminders about optional entries.
- For primary research you should upload a flow diagram (single-side of A4), as a separate .pdf file, for submission with your application form. This should illustrate the study design and the flow of participants (if appropriate). If the project consists of more than one work package, consider a diagram that conveys the sequence and timing of research packages as well as how the work packages are linked. Applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful. The PDF file must be submitted along with your application form.
- Submit a list of references used throughout your proposal (maximum 1 sides of A4).
- Upload any other requested documents e.g. cover letter, collaborative documents, as dictated by the specification of the call.
Giving others access to the form
- Co-applicants: Access to your application is through your user login to the NETSCC MIS. This should not be shared. The Stage 1 application does not require co-applicants to complete this form however as lead applicant you must ensure they are aware of being involved in the study team. If you want to share your form with your co-applicants, please create a PDF of the form and send it to them. Options to create a .pdf are available on the Home page and the Review and Submit page.
- Signatories: You are not required to provide signatories for Stage 1 applications.
Guidance for using the electronic online Stage 2 application form
To access the application form for Stage 2 applications only
If you have been shortlisted from a Stage 1 form:
The ‘Stage 2 Application’ task can be accessed at any time until you either submit the application (using the Submit button in the application process which will appear once all the validation is complete) or the call closes.
Clicking on the Stage 2 Application link takes you to the application’s main page where you can complete your application information (clicking on this link will not submit an incomplete application).
Additional guidance will be available on most screens as you progress through your application.
The NETSCC MIS can always be accessed directly at https://netscc-mis.nihr.ac.uk/ for you to go to your home page where all your applications and other tasks will be listed.
To submit a Stage 2 application
In order to submit a Stage 2 application to the programme you must:
- Complete all mandatory fields. The final review and submit page of the application provides a final check of the mandatory fields as well as providing reminders about optional entries.
- Submit a Detailed Research Plan, which should:
- Have a font size of 11 Arial
- Not exceed 20 A4 pages
- Have a header containing your allocated project reference number if known
- Have a footer showing your page numbers
- Be converted to a .PDF version before uploading it
- Submit a flow diagram (single-side of A4), as a separate .pdf file, for submission with your application form. This should illustrate the study design and the flow of participants (if appropriate). If the project consists of more than one work package, consider a diagram that conveys the sequence and timing of research packages as well as how the work packages are linked. Applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful. The .pdf file must be submitted along with your application form.
- Submit a CTU letter of support if appropriate to the study. This is not a mandatory upload.
- Submit a list of references used throughout your proposal (maximum 3 sides of A4).
- Upload any other requested documents e.g. cover letter, collaborative documents as dictated by the specification of the call.
Giving others access to the Stage 2 form
Guidance for how co-applicants complete their sections can be found at: www.nihr.ac.uk/about-us/documents/NETSCC/MIS/MIS-brief-for-Co-Applicants.pdf
Including co-applicants in your Stage 2 application
Access to your application is through your NETSCC MIS user login. This should not be shared. The Stage 2 application is designed as a collaborative submission. As the lead applicant, you can nominate co-applicants to provide their CV information and collaborate on sections of the application. You select the type of access they have to the application. As a result of the nomination, your co-applicants will be invited via email to login to the MIS, accept their role and complete their application tasks.
If your application includes co-applicants, you will not be able to complete and submit your application until the co-applicant has provided the information that we require from them.
Once you have completed the details for each co-applicant you have to select the option ‘notify’ on the Research Team Instructions page. This will then prompt an email to be sent to each co-applicant with a task Accept Stage 2 Application Participation (Co-Applicant) for them to approve involvement with the project in question. If the applicant agrees this generates two new tasks which will appear on their homepage.
1) Collaborate on Stage 2 Application (Co-Applicant) which requires the co-applicant to update their CV details.
And the other task:
2) Stage 2 Application, depending on the access permissions granted by the lead applicant, allows the co-applicant to read and/or amend any details in the application. It is the responsibility of the lead applicant to ensure that the co-applicants complete all the tasks generated.
- Enter co-applicants details accurately as we will use these to contact them (the exact email address used as their MIS username is essential to ensure they receive the automatic communication as part of the application process).
Please make sure that you:
- Allow sufficient time for your co-applicants to complete both parts of their task in the online form before the application deadline.
Guidance for how signatories complete their sections can be found at: https://netscc-webapps.dev.soton.ac.uk/MISHelp/MIS-brief-for-Supporting-Role-Signatories.pdf
Instead of requiring wet ink signatures (for roles such as Sponsor, Department Head, Financial Director, NHS facilities Manager etc.) on a paper copy of the application form, you will be asked to provide contact information (including a valid individual’s email address) about the required signatories for the Stage 2 application so that they can complete their approvals electronically. This process replaces the need for ‘wet ink’ signatures with an electronic version.
For signatories this is a two stage process and requires those nominated to first complete an ‘agree to participate’ task prior to application submission, followed by a ‘confirmation’ task immediately after submission of the application.
Firstly, you the lead applicant will be able to ‘Notify’ the signatories which will automatically invite them via email to register/login to the MIS and accept their role.
Following submission the lead applicant will notify each signatory using the MIS, they will then acknowledge that they have seen and support your completed submitted application in time for the deadline by submitting the ‘Provide full application signatures’ task. They will be able to see a PDF copy of your completed application via the system.
The Programme acknowledges that it may not be possible for you to obtain confirmation from your Signatories immediately after submission, however; it remains your responsibility to obtain these electronic approvals within two weeks of the submission deadline. You can check that your signatories have completed the approval process on your MIS task page.
Once all signatories have completed their task you should take a screen shot of the completed page and email it to the relevant funding team. For contact details see section 17. Assistance, below.
We strongly recommend that you ensure your finance signatories have read the costing section of your application prior to submission as changes can’t be made to your finance section after the application is submitted.
Completing the form
In line with other health research funders, NIHR have recently started implementing a new researcher identifier scheme – ORCiD. ORCID provides a digital identifier that, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between researchers and professional activities ensuring that work is recognised.
Applicants can now update their MIS profile with their ORCiD ID, a process that will become mandatory for all applicants in the future. This ID will only need to be entered once.
To add your ORCiD ID to your MIS contact record, log in to the MIS and go to your profile. Click the link ‘View ORCiD record’ and follow the on-screen instructions. You will then be returned to the MIS and the profile field for your ORCiD number will automatically be populated. You will only have to do this once.
N.B. For a Stage 2 application this is a mandatory requirement.
Saving your form
As you work through the application, you are asked to save each page. This will save all the information you have submitted so far. You can save the form at any point and leave the application prior to submission. The save button is always located at the bottom of each page of the application. Large text areas on the form also have their own save button beside them. The application task will remain on your home page until complete and submitted or the deadline for the application has passed.
It is important to remember to ‘Save’ each section as you go through the form before navigating away from the page.
There is a security time out set on the MIS so that after 60 minutes of inactivity, the user will be logged out of the MIS. It is advisable therefore to save your work at regular intervals using the save button on any page. The NETSCC MIS will give you a warning that you are due to be timed out 10 minutes before it times you out. If this message is displayed, you should close the pop-up.There is a left hand navigation menu in the application so you can select specific parts of the form to complete, however you should always ensure that you save any information entered on your page before using this left hand menu.
Leaving the application task
You can leave your application task at any time. As long as you have saved any new information you have entered for the application, you can navigate to your home page or log out of the NETSCC MIS system.
If you encounter any problems with the NETSCC MIS system, you should contact the programme funding support team via email. The contact details can be found on the NIHR website.
Space restrictions when entering text
You should be aware that there are character limits set for each text box within the application form. For larger text areas these are indicated with ‘Limit’ and ‘Remaining’ at the bottom of the text entry box. Please note that the system does not provide a spell checker. Carriage returns and spaces are counted as characters. The character count will be slightly less than that of a Microsoft word character count.
The form counts all blank space as a part of the content of each box, so if you are short of space it will help if you delete extra carriage returns and place any bulleted lists into paragraph format.
Use of non-standard characters
You are advised not to use any non-standard characters in your text; in particular, you may experience a technical difficulty that affects the use of these characters ‘<’ ‘>’ ‘≥’ and ‘≤’. The system will currently strip these characters out of the content of the text without warning.
If you need to use these symbols, then please replace them with words (i.e. less than or greater than, or less than or equal to or greater than or equal to). You will not be able to submit the form if you have either of these symbols or any other non-alphabetical or non-numerical characters in your text. For these reasons it is advisable that you either type text directly into the form or ensure these characters are not included in any text that you copy and paste from other documents.
You may wish to include URL links to your application or refer to URL links in a body of your text. You are advised not to use any URL shortening service such as ‘tiny.cc’ when completing your application. This type of shortening service is associated with hacking and spamming (as it promotes the sending of links that are unclear where they are pointing).
Technical support documents including how to spell check, resize text boxes and use Mac/iPads can be found here
Review and Submit Application
Please ensure that before you submit your application, you have completed the required fields and saved a version of your form. You must submit your application form and flow diagram / references where required, by the stated deadline before 1pm. We are unable to grant any time extensions and the deadline will be strictly observed. You should therefore plan your application carefully. We will not enter into negotiations for extensions.
Stage 1 and Stage 2 applications must be submitted electronically.
The Programmes no longer require paper copies of submissions.
Submit your application using the Submit button on the last page of the web form. Please note that the Submit button will not appear unless all necessary sections have been completed. Warning signs ( ! ) may appear to indicate that you may have omitted some information but this sign indicates the information is not mandatory and you can submit without it.
The section/form has been filled out correctly
Mandatory information has not been provided and the task cannot be submitted until this has been completed (
( ! )
This section has not been completed but is not mandatory
We strongly advise applicants at this point to check that all sections are completed and the correct documents have been uploaded into the system as they cannot be altered once submitted.
Once all sections have been completed and show as green ticks (or as a yellow advisory exclamation mark) a submit button will appear in the top left hand corner of the page and the form can be submitted to the programme.
You will then receive an automated confirmation email from the programme. If you do not receive an email please contact us immediately as there may be an issue with your submission.
Seven days prior to the closing date you will receive an email reminder that you have an open application (i.e. not submitted). The Programmes no longer support ‘rolling over’ of applications to a subsequent call.
If, after carefully reading all the instructions, you still have difficulties completing your application, please visit the NIHR website which has various supporting documents available.
Any questions, queries or requests for clarification in relation to the call you are applying to should be to one of the following e-mail addresses with the reference number and title for the call for proposals as the email header.
Please be aware that while every effort will be made to respond to enquiries in a timely fashion, it is advisable to send queries in as far in advance of the call closing date as possible to ensure we can respond whilst still leaving you enough time to complete your application.